Methods for managing scalp conditions

ABSTRACT

This application relates to a pharmaceutical composition for the prevention, treatment, and management of scalp conditions, such as dandruff, seborrheic dermatitis, psoriasis, folliculitis, and hair thinning including a therapeutically effective amount of an acidic component of a hydroxyacid or tannic acid, or a pharmaceutically acceptable salt thereof. A preferred anti-dandruff composition and method of managing dandruff includes a therapeutically effective amount of the acid component, a vitamin A component, and an anti-growth agent. A preferred anti-hair thinning composition and method of managing thinning hair includes a therapeutically effective amount of the acidic component, a niacin component present in an amount sufficient to locally increase blood circulation, and a 5-α reductase inhibitor. The invention also relates to a method of treating chemically processed hair by administering to a patient an amount of an acidic component of a hydroxy acid or tannic acid, or a pharmaceutically acceptable salt thereof, in an amount sufficient to essentially close the cuticle and inhibit modification of the chemically processed hair.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a divisional of application Ser. No. 09/368,078, filed Aug. 3,1999, now U.S. Pat. No. 6,271,246 which is a divisional of Ser. No.09/123,484, filed Jul. 27, 1998, now U.S. Pat. No. 6,207,694 thecontents of which are expressly incorporated herein by referencethereto.

TECHNICAL FIELD

The application relates to pharmaceutical compositions, as well asmethods, to normalize skin for the prevention, treatment and managementof scalp conditions.

BACKGROUND OF THE INVENTION

Human skin is a composite material of the epidermis and the dermis. Thetopmost part of the epidermis is the stratum corneum. This layer is thestiffest layer of the skin, as well as the one most affected by thesurrounding environment. Below the stratum corneum is the internalportion of the epidermis. Below the epidermis, the topmost layer of thedermis is the papillary dermis, which is made of relatively looseconnective tissues that define the micro-relief of the skin. Thereticular dermis, disposed beneath the papillary dermis, is tight,connective tissue that is spatially organized. The reticular dermis isalso associated with coarse wrinkles. At the bottom of the dermis liesthe subcutaneous layer.

The principal functions of the skin include protection, excretion,secretion, absorption, thermoregulation, pigmentogenesis, accumulation,sensory perception, and regulation of immunological processes. Thesefunctions are detrimentally affected by, for example, dryness, yeast,and structural changes in the skin, such as due to aging and excessivesun exposure.

Many hair care products tend to include alkaline components, which tendto open pores in the scalp. While these products may improve or alterhair appearance, they may exacerbate various scalp conditions, such asdandruff, psoriasis, and seborrhea.

Various pharmaceuticals that frequently contain one or more alphahydroxy acids, such as glycolic acid, have been used to prevent andtreat certain cellular, skin, hair and other conditions. For example,U.S. Pat. No. 4,668,509 discloses polythioalkanecarboxylic anionicproducts and their preparation and use in cosmetic compositions and hairtreatment compositions, such as shampoos.

U.S. Pat. No. 4,814,166 discloses polyanionic oligomer compoundssuitable for use in keratin fiber treatment, such as hair, which may beadministered in a shampoo. These compounds are alleged to hold hair withsuppleness and without significant hardening of the hair.

U.S. Pat. No. 5,344,971 discloses mercapto acids, such as thiolacticacid (2-mercaptopropionic acid), that are used as reducing agents forthe permanent reshaping of hair or for depilatory milks and creams.

An article entitled “Hydroxy Acids and Skin Aging” discloses the use ofhydroxy and other acids as skin peels and emollients that canmoisturize, stimulate, and exfoliate the skin. [Smith, W.,Soap/Cosmetics/Chemical Specialties, pp. 54-58, 76, September, 1993.]. Astudy was conducted with hydroxy, keto, carboxylic, or dicarboxylicacids, including glycolic and salicylic acids, to determine long-termrejuvenating benefits. The study noted that higher pH formulationsresulted in less stimulatory activity and lower irritation, andconcluded that various non-hydroxy acids would be expected to deliverlong-term rejuvenating benefits. Id. at 58.

One publication, WO 95/33438, discloses skin or hair care productshaving an agent acting cosmetically on the hair or skin, such asthioglycolic acid preferably with an ammonium salt. The agent isabsorbed in a fibrous material containing amino groups, such ascellulose based-fiber containing polysilicic acid.

U.S. Pat. No. 5,422,370 discloses methods of using hydroxyacid orrelated compounds, such as alpha 2-hydroxypropanoic acid (lactic acid),for the treatment of wrinkles. These compounds are also disclosed to beeffective for enhancing the topical effects of other cosmetic andpharmaceutical agents for treatment of conditions such as dry skin,ichthyosis, eczema, palmar and plantar hyperkeratoses, dandruff, acne,pruritis, psoriasis, Darier's disease, lichen simplex chronicus, andwarts. Similarly, U.S. Pat. No. 5,547,988 discloses methods for reducingthe appearance of skin changes associated with aging, such as wrinkles,by topically applying a compound of glycolic acid, lactic acid, citricacid, or a salt thereof.

U.S. Pat. No. 5,587,149 discloses improved stable emulsions ofpolyethylene glycol-in-oil for topical application to the skin thatcontain one or more water soluble active ingredients, such as Vitamin C,glycolic acid, and the like.

Despite these references, there is still a need for pharmaceuticalcompositions and methods for the prevention, treatment, and managementof scalp conditions, such as dandruff, psoriasis, and seborrhea. Thepresent invention advantageously provides pharmaceutical compositions,as well as methods for prevention and treatment, by administering suchcompositions to repair and normalize the scalp for the prevention andtreatment of scalp conditions.

SUMMARY OF THE INVENTION

The present invention relates to an anti-dandruff pharmaceuticalcomposition for administration to a scalp including an acidic componenthaving a hydroxy acid or tannic acid, or a pharmaceutically acceptablesalt thereof, in an amount sufficient to exfoliate at least a portion ofthe scalp, a vitamin A component in an amount sufficient to inhibitoverproduction of stratum corneum on the scalp, and an anti-growth agentto inhibit fungus, yeast, bacteria, or a mixture thereof adjacent thescalp. The compositions preferably include a pharmaceutically acceptablecarrier or excipient.

In one embodiment, the acidic component includes an alpha-hydroxy acid,beta-hydroxy acid or tannic acid, the vitamin A component includesretinyl palmitate, and the anti-growth agent includes clotrimazole. In apreferred embodiment, the acidic component includes at least one ofglycolic acid, lactic acid, citric acid, salicylic acid, or tannic acid.In another embodiment, the acidic component is present in an amount fromabout 0.1 to 8 weight percent, the vitamin A component is present in anamount from about 0.01 to 1 weight percent, and the anti-growth agent ispresent in an amount from about 0.1 to 1.5 weight percent, of thecomposition. In a preferred embodiment, the pharmaceutical compositionfurther includes at least one of a surfactant, a stabilizer, apreservative, a moisturizer, anti-inflammatory agent, anti-oxidant, anda coloring agent, which together may be present in an amount from about10.1 to 99.1 weight percent of the composition. Also encompassed by theinvention are a shampoo, cream, or gel including the pharmaceuticalcomposition described above.

The invention also relates to an anti-hair thinning pharmaceuticalcomposition for administration to a scalp having an acidic componentincluding a hydroxy acid or tannic acid in an amount sufficient toexfoliate at least a portion of the scalp, or a pharmaceuticallyacceptable salt thereof, a niacin component present in an amountsufficient to locally increase blood circulation; and a 5-α reductaseinhibitor in an amount sufficient to inhibit conversion of testosteroneto dihydro-testosterone. The compositions preferably include apharmaceutically acceptable carrier or excipient. In one embodiment, theacidic component includes an alpha-hydroxy acid, beta-hydroxy acid, ortannic acid, the niacin component includes nicotinate, and the 5-αreductase inhibitor includes at least one of finasteride or Saw PalmettoExtract. In a preferred embodiment, the acidic component includesglycolic acid, lactic acid, citric acid, salicylic acid, or tannic acid.In another embodiment, the acidic component is present in an amount fromabout 0.1 to 8 weight percent, the niacin component is present in anamount from about 0.01 to 1 weight percent, and the 5-α reductaseinhibitor is present in an amount from about 0.1 to 1 weight percent, ofthe composition. In a preferred embodiment, the composition includes atleast one of a surfactant, a stabilizer, a preservative, a moisturizer,anti-inflammatory agent, anti-oxidant, and a coloring agent, whichtogether may be present in an amount from about 10.1 to 99.1 weightpercent of the composition. In a preferred embodiment, the acidiccomponent and the niacin component are adapted for topicaladministration and the 5-α reductase inhibitor is adapted for oraladministration. The invention also encompasses a shampoo, cream, or gelincluding the pharmaceutical composition described above.

The invention also relates to a method of managing a scalp conditionwhich includes administering to a patient a therapeutically effectiveamount of an acidic component having a hydroxy acid or tannic acid, or apharmaceutically acceptable salt thereof, a vitamin A component, and ananti-growth agent to inhibit fungus, yeast, bacteria, or a mixturethereof that may be present adjacent the scalp. In a preferredembodiment, the scalp condition treated is at least one of dandruff,seborrheic dermatitis, psoriasis, folliculitis, or other infectious orscaling conditions.

In a preferred embodiment, the active ingredients are administeredtopically. In another embodiment, the administering is by at least oneof a shampoo, aerosol spray, gel, paste, cream, lotion, sponge,emulsion, or ointment. In a preferred embodiment, from about 1 mg to10,000 mg of the acidic component, vitamin A component, and anti-growthagent together are administered. In another embodiment, the acidiccomponent, vitamin A component, and anti-growth agent are administeredconcurrently. In another embodiment, the acidic component, vitamin Acomponent, and anti-growth agent are administered concurrently with atleast one additional pharmaceutical composition for the prevention ortreatment of a scalp condition. In another embodiment, the methodfurther includes administering at least one of a surfactant, stabilizer,preservative, moisturizer, anti-inflammatory agent, anti-oxidant, orcoloring agent. In a preferred embodiment, the acidic component includesan alpha-hydroxy acid or tannic acid, the vitamin A component includesretinyl palmitate, and the anti-growth agent includes clotrimazole.

The invention also relates to a method of managing hair thinning whichincludes administering to a patient a therapeutically effective amountof an acidic component having a hydroxy acid or tannic acid, or apharmaceutically acceptable salt thereof, a niacin component present inan amount sufficient to locally increase blood supply, and a 5-αreductase inhibitor.

In a preferred embodiment, the active ingredients are administeredtopically. In a more preferred embodiment, the acidic component andniacin component are topically administered and the 5-α reductaseinhibitor is orally administered. In another embodiment, theadministering is by at least one of a shampoo, aerosol spray, gel,paste, cream, lotion, sponge, emulsion, or ointment. In a preferredembodiment, from about 1 mg to 10,000 mg of the acidic component, niacincomponent, and 5-α reductase inhibitor are administered. In anotherembodiment, the acidic component, niacin component, and 5-α reductaseinhibitor are administered concurrently. In yet another embodiment, theacidic component, niacin component, and 5-α reductase inhibitor areadministered concurrently with at least one additional pharmaceuticalcomposition for the prevention or treatment of a scalp condition. Inanother embodiment, the method further includes administering at leastone of a surfactant, stabilizer, preservative, moisturizer,anti-inflammatory agent, anti-oxidant, or coloring agent. In a preferredembodiment, the acidic component includes an alpha-hydroxy acid ortannic acid, the niacin component includes nicotinate, and the 5-αreductase inhibitor includes at least one of finasteride or Saw PalmettoExtract.

The invention further relates to a method of treating chemicallyprocessed hair having a plurality of cuticle by administering to apatient an amount of an acidic component including a hydroxy acid ortannic acid, or a pharmaceutically acceptable salt thereof, in an amountsufficient to essentially close the cuticle.

In a preferred embodiment, the administering is topically applied. Inanother embodiment, the administering is by at least one of a shampoo,aerosol spray, gel, paste, cream, lotion, sponge, emulsion, or ointment.In a preferred embodiment, from about 1 mg to 10,000 mg of the acidiccomponent is administered. In another embodiment, the acidic componentis administered concurrently with at least one additional pharmaceuticalcomposition for the prevention or treatment of a scalp condition. In apreferred embodiment, the method further includes administering at leastone of a surfactant, stabilizer, preservative, moisturizer,anti-inflammatory agent, anti-oxidant, or coloring agent. In anotherpreferred embodiment, the acidic component includes an alpha-hydroxyacid or tannic acid.

The ranges of the components of the pharmaceutical composition may vary,but the active ingredients should be understood to add to 100 weightpercent of the active pharmaceutical composition.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A formulation for the prevention, treatment, and management of scalpconditions, such as dandruff, psoriasis, and seborrhea, has now beendiscovered. Moreover, the management of the scalp may advantageously beaccomplished by the administration of the pharmaceutical composition ofthe present invention.

Methods for administering the compositions herein are also encompassedby the invention. Such methods include the prevention, treatment, ormanagement of: dandruff, eczema, hair thinning, irritation, psoriasis,folliculitis, scaling, seborrhea or seborrheic dermatitis, all whilereducing environmental damage to the hair and scalp and maintainingcolor in chemically processed hair as advantageous benefits. Thecompositions may be prepared in high concentrations for administrationby professionals in a salon, as well as lower concentrations that aresafer for home use. The methods of the present invention also includeadministering mono- or poly-hydroxy or tannic acids for treatingchemically processed hair, which advantageously closes or essentiallycloses the hair cuticle. The closing of the cuticle helps “lock in” haircolor to prevent fading or washout of the chemically processed hair.

The pharmaceutical composition includes the combination of a number ofdifferent components that interact to provide the desired improvementsto the skin. The compositions include an acidic component including oneor more mono- or poly-hydroxy acids or tannic acid, a mixture thereof,or a pharmaceutically acceptable salt or ester thereof One of ordinaryskill in the art will be readily able to select and prepare suitablemono- or poly-hydroxy acids for use in the composition of the invention,for example, alkyl hydroxycarboxylic acids, aralkyl and arylhydroxycarboxylic acids, polyhydroxy-carboxylic acids, andhydroxy-polycarboxylic acids. To assist one of ordinary skill in theart, some preferred mono- or poly-hydroxy acids include: 2-hydroxyaceticacid (glycolic acid); 2-hydroxypropanoic acid (lactic acid); 2-methyl2-hydroxypropanoic acid; 2-hydroxybutanoic acid; phenyl 2-hydroxyaceticacid; phenyl 2-methyl 2-hydroxyacetic acid; 3-phenyl 2-hydroxyaceticacid; 2,3-dihydroxypropanoic acid; 2,3,4-trihydroxybutanoic acid;2,3,4,5,6-pentahydroxyhexanoic acid; 2-hydroxydodecanoic acid;2,3,4,5-tetrahydroxypentanoic acid; 2,3,4,5,6,7-hexahydroxyheptanoicacid; diphenyl 2-hydroxyacetic acid; 4-hydroxymandelic acid;4-chloromandelic acid; 3-hydroxybutanoic acid; 4-hydroxybutanoic acid;2-hydroxyhexanoic acid; 5-hydroxydodecanoic acid; 12-hydroxydodecanoicacid; 10-hydroxydecanoic acid; 16-hydroxyhexadecanoic acid;2-hydroxy-3-methylbutanoic acid; 2-hydroxy4-methylpentanoic acid;3-hydroxy-4-methoxymandelic acid; 4-hydroxy-3-methoxymandelic acid;2-hydroxy-2-methylbutanoic acid; 3-(2-hydroxphenyl) lactic acid;3-(4-hydroxyphenyl) lactic acid; hexahydromandelic acid;3-hydroxy-3-methylpentanoic acid; 4-hydroxydecanoic acid;5-hydroxydecanoic acid; aleuritic acid; 2-hydroxypropanedioic acid;2-hydroxybutanedioic acid; erythraric acid; threaric acid; arabiraricacid; ribaric acid; xylaric acid; lyxaric acid; glucaric acid;galactaric acid; mannaric acid; gularic acid; allaric acid; altraricacid; idaric acid; talaric acid; 2-hydroxy-2-methylbutanediodic acid;citric acid, isocitric acid, agaricic acid, quinic acid, glucoronicacid, glucoronolactone, galactoronic acid, galactoronolactone, uronicacids, uronolactones, ascorbic acid, dihydroascorbic acid,dihydroxytartaric acid, tropic acid, ribonolactone, gluconolactone,galactonolactone, gulonolactone, mannonolactone, citramalic acid;pyruvic acid, hydyroxypyruvic acid, hydroxypyruvic acid phosphate andesters thereof; methyl pyruvate, ethyl pyruvate, propyl pyruvate,isopropyl pyruvate; phenyl pyruvic acid and esters thereof; methylphenyl pyruvate, ethyl phenyl pyruvate, propyl phenyl pyruvate; formylformic acid and esters thereof; methyl formyl formate, ethyl formylformate, propyl formyl formate; benzoyl formic acid and esters thereof;methyl benzoyl formate, ethyl benzoyl formate and propyl benzoylformate; 4-hydroxybenzoyl formic acid and esters thereof;4-hydroxyphenyl pyruvic acid and esters thereof; and 2-hydroxyphenylpyruvic acid and esters thereof. The hydroxy acids are more preferablyselected from one or more alpha-hydroxy acids or beta-hydroxy acids,most preferably from glycolic, lactic, citric, or salicylic acid. Itshould be understood that one or more derivatives of the above acidiccomponent, such as esters or lactones thereof, are also suitably used.One of ordinary skill in the art will also understand that varioushydroxy acids described in U.S. Pat. Nos. 5,547,988 and 5,422,370 arealso suitable for use in the compositions and methods of the invention.The acidic component is present in the composition and methods in anamount sufficient to exfoliate, i.e., remove dead or dying skin cells,from at least a portion of the scalp. The acidic component is typicallypresent in an amount from about 0.1 to 8 weight percent, preferablyabout 0.5 to 5 weight percent, more preferably from about 1 to 3 weightpercent of the composition. For example, the acidic component may befrom about 0.2 to 10 weight percent GLYPURE, which contains 70 weightpercent glycolic acid, in combination with about 0.1 to 0.3 weightpercent salicylic acid.

Compositions and methods for managing dandruff, seborrheic dermatitis,psoriasis, folliculitis, and other scaling or infectious scalpconditions, also include a vitamin A component and an anti-growth agent.The vitamin A component preferably is retinyl palmitate. The vitamin Acomponent is present in an amount sufficient to normalize epidermalgrowth by inhibiting overproduction of the stratum corneum. The vitaminA component is typically present in an amount from about 0.01 to 1weight percent, preferably 0.05 to 0.8 weight percent, and morepreferably 0.1 to 0.5 weight percent of the composition. Vitamin A istoxic at high levels, such that no more than 400,000 IU should becumulatively ingested per day for greater than six months.

Any pharmaceutically acceptable anti-growth agent may be used,preferably an antifungal agent, antiyeast agent, or antibacterial agent,more preferably triclosan, clotrimazole, and the like, and mixturesthereof. The anti-growth agent is typically present in an amount fromabout 0.1 to 1.5 weight percent, preferably from about 0.3 to 1.2 weightpercent, and more preferably from about 0.5 to 1 weight percent of thecomposition. The anti-growth agent may inhibit the fungus Pityrosporumovale, which tends to be present in patients having dandruff orseborrheic dermatitis. Together, the acidic component, Vitamin Acomponent, and anti-growth agent facilitate exfoliation of dead skin,facilitate hydration of the scalp, and inhibit the presence of yeast orfungus, such as all of which assist in the management of dandruff,psoriasis, folliculitis, seborrheic dermatitis, and other inflammatoryor scaling conditions of the scalp.

Compositions and methods for the management of thinning hair include aniacin component and a 5-α reductase inhibitor, in addition to theacidic component. The niacin component (vitamin B₃) may be anypharmaceutically acceptable niacin component, preferably niacinamide ornicotinate, more preferably nicotinate. The niacin component should bepresent in an amount sufficient to facilitate improved blood circulationin the scalp, which may help inhibit hair loss. Thus, the niacincomponent is typically present in an amount from about 0.01 to 1 weightpercent, preferably from about 0.05 to 0.8 weight percent, and morepreferably from about 0.1 to 0.5 weight percent of the composition.

Any pharmaceutically acceptable 5-α reductase inhibitor may be used inthe anti-hair thinning compositions, such as finasteride, Saw PalmettoExtract (Serenoa repens), MK-386, LY191704, turosteride, PNU 157706,FK-143, GG-745, ONO-9302, and the like, and mixtures thereof. Apreferred 5-α reductase inhibitor is Saw Palmetto Extract (SerenoaSerrulata). The 5-α reductase inhibitor is typically present in anamount sufficient to inhibit conversion of testosterone in the scalp todihydro-testosterone, the latter of which is believed to increase hairthinning. The 5-α reductase inhibitor is typically present in an amountfrom about 0.01 to 1 weight percent, preferably about 0.05 to 0.5 weightpercent, and more preferably about 0.08 to 0.2 weight percent of thecomposition. The hydroxy acid, niacin component, and 5-α reductaseinhibitor together facilitate exfoliation of dead skin, improve bloodcirculation, and ultimately inhibit and/or reduce hair loss.

In a preferred embodiment, the compositions all contain one or moresurfactants, stabilizers, preservatives, moisturizers, coloring agents,anti-inflammatory agents, anti-oxidants, water, and the like, andmixtures thereof. The water used is preferably deionized water. Itshould be understood that water includes the remainder of a givencomposition after other ingredients are determined. Although anypharmaceutically acceptable surfactant, stabilizer, preservative,moisturizer, or coloring agent may be used, certain compounds ormixtures are preferred as discussed below.

Preferred surfactants, including both the foaming and non-foaming type,include sodium laureth sulfate, disodium cocoamphodiacetate, and thelike, and mixtures thereof. The surfactant component may be present inan amount from about 10 to 90 weight percent, preferably about 20 to 80,and more preferably about 30 to 70 weight percent of the composition.

A preferred stabilizer includes glycol stearate. The stabilizer, whenused, is typically present in an amount from about 0.1 to 5 weightpercent of the composition.

Preferred preservatives include tetrasodium ethylene-diamine tetraaceticacid (EDTA), methylparaben, benzophenone-4, methylchloroisothiazolinone,methylisothiazolinone, and the like, and mixtures thereof.Preservatives, when used, are typically present in an amount from about0.01 to 6 weight percent, preferably about 0.05 to 4 weight percent, andmore preferably from about 0.1 to 2 weight percent.

Preferred moisturizers include wheat protein (e.g., laurdimoniumhydroxypropyl hydrolyzed wheat protein), hair keratin amino acids,sodium peroxylinecarbolic acid, panthenol, tocopherol (Vitamin E),dimethicone, and the like, and mixtures thereof. Sodium chloride mayalso be present, particularly when hair keratin amino acids are includedas a moisturizer. Moisturizers are typically present in an amount fromabout 0.01 to 2 weight percent, preferably about 0.05 to 1.5 weightpercent, more preferably from about 0.1 to 1 weight percent of thecomposition.

Preferred coloring agents include FD&C Green No. 3, Ext. D&C Violet No.2, FD&C Yellow No. 5, FD&C Red No. 40, and the like, and mixturesthereof. The coloring agents are preferably used, and when used aretypically present in an amount from about 0.001 to 0.1 weight percent,and preferably from about 0.005 to 0.05 weight percent of thecomposition.

Preferred anti-inflammatory agents include any pharmaceuticallyacceptable compounds suitable for administration orally or topically,preferably allantoin. The anti-inflammatory agents, when present, areused in an amount sufficient to inhibit or reduce inflammation,preferably in an amount from about 0.1 to 2 weight percent, preferablyfrom about 0.3 to 1.5 weight percent, and more preferably from about 0.3to 1 weight percent of the composition.

Anti-oxidants of both the enzymatic and non-enzymatic type may beincluded in the compositions and methods of the invention. For example,superoxide dismutase (SOD), catalase, and glutathione peroxidase arenatural enzymatic anti-oxidants used by the body that may besupplemented with the compositions herein. Suitable non-enzymaticanti-oxidants include such as Vitamin E (e.g. tocopherol), Vitamin C(ascorbic acid), carotenoids, Echinacoside and caffeoyl derivatives,oligomeric proanthocyanidins or proanthanols (e.g., grape seed extract),silymarin (e.g., milk thistle extract, Silybum marianum), ginkgo biloba,green tea polyphenols, and the like, and mixtures thereof. Carotenoidsare powerful anti-oxidants, and they include beta-carotene,canthaxanthin, zeaxanthin, lycopen, lutein, crocetin, capsanthin, andthe like. Indeed, any pharmaceutically acceptable compounds suitable foradministration orally or topically may be used as an anti-oxidant in thecompositions. Preferably, the anti-oxidant component includes Vitamin E,Vitamin C, or a carotenoid. The anti-oxidant component, when used, ispresent in an amount sufficient to inhibit or reduce the effects offree-radicals at the scalp. The anti-oxidant component may be present inan amount from about 0.001 to 1 weight percent, preferably from about0.01 to 0.5 weight percent of the composition.

Application of chemicals to the hair, such as for coloring or other hairtreatment, requires the cuticles to be opened, which may be accomplishedby using any of a variety of alkaline components suitable forapplication to the hair. It should be understood that the application ofthe acidic component, however, will close or essentially close thecuticle incidental to the methods of managing scalp conditions, asdiscussed herein. Thus, chemical processing of the hair is rendered moredifficult after application of the compositions of the presentinvention. However, when it is desired to specifically protectchemically processed hair, the compositions herein may be administeredsubsequent to, preferably immediately subsequent to, chemical processingof the hair. By “immediately” it is meant that the compositions hereinare administered within 4 hours, preferably within 1 hour, and morepreferably within 30 minutes of the chemical processing. Thus, in apreferred embodiment for protecting chemically processed hair, a patientmay optionally have their hair conventionally shampooed and rinsed,chemically processed, and then have the compositions of the inventionadministered to protect the processing by closing or essentially closingthe cuticle.

The term “scalp conditions” as used herein means conditions includingdandruff, eczema, hair thinning, irritation, psoriasis, scaling,folliculitis, seborrhea or seborrheic dermatitis, and the like.

The terms “managing” or “management” as used herein includes one or moreof the prevention, treatment, or modification of a condition.

The term “environmental damage” as used herein means weather or otherdamage to the scalp or hair from exposure to one or more of water, sun,pollution, overdrying, overteasing, and the like.

The term “therapeutically effective amount” means that amount of thepharmaceutical composition that provides a therapeutic benefit in thetreatment, prevention, or management of scalp conditions.

The magnitude of a prophylactic or therapeutic dose of the compositionin the acute or chronic management of scalp conditions will vary withthe severity of the condition to be treated and the route ofadministration. The dose, and perhaps the dose frequency, will also varyaccording to the age, body weight, and response of the individualpatient. In general, a preferred topical daily dose range, in single ordivided doses, for the conditions described herein should be from about1 mg to 20,000 mg, more preferably about 2,000 mg to 16,000 mg, and mostpreferably about 6,000 mg to 10,000 mg of the active components (i.e.,excluding excipients and carriers).

Those of ordinary skill in the art will also understand that topicaleffectiveness of pharmaceuticals requires percutaneous absorption andbioavailability to the target site. Thus, the compositions and methodsof the invention require penetration through the stratum corneum intothe epidermal layers, as well as sufficient distribution to the sitestargeted for pharmacologic action.

It is further recommended that children, patients aged over 65 years,and those with impaired renal or hepatic function initially receive lowdoses, and that they then be titrated based on individual response(s) orblood level(s). It may be necessary to use dosages outside these rangesin some cases, as will be apparent to those of ordinary skill in theart. Further, it is noted that the clinician or treating physician willknow how and when to interrupt, adjust, or terminate therapy inconjunction with individual patient response.

The term “unit dose” is meant to describe a single dose, although a unitdose may be divided, if desired. About 1 to 2 unit doses of the presentinvention are typically administered per day, preferably about 1 doseper day.

Any suitable route of administration may be employed for providing thepatient with an effective dosage of the composition according to themethods of the present invention, including oral, intraoral, rectal,parenteral, topical, epicutaneous, transdermal, subcutaneous,intramuscular, intranasal, sublingual, buccal, intradural, intraocular,intrarespiratory, or nasal inhalation and like forms of administration.Topical administration is generally preferred for the compositions andmethods of the invention, although oral administration is preferred forthe 5-α reductase inhibitor. Suitable dosage forms include dispersions,suspensions, solutions, aerosols, sponges, cotton applicators, and thelike, with topical dosage forms such as shampoos being preferred. Asunscreen dosage form is one preferred embodiment for methods andcompositions for the management of thinning hair, since extra protectionis required when more scalp is exposed to harmful ultraviolet radiation.In a sunscreen dosage form, it is preferred to include benzophenone-4,which provides the scalp with some sunscreen protection factor fromultraviolet radiation.

The pharmaceutical compositions used in the methods of the presentinvention include the active ingredients described above, and may alsocontain pharmaceutically acceptable carriers, excipients and the like,and optionally, other therapeutic ingredients.

The term “pharmaceutically acceptable salt” refers to a salt preparedfrom pharmaceutically acceptable non-toxic acids or bases includinginorganic or organic acids. Examples of such inorganic acids arehydrochloric, hydrobromic, hydroiodic, sulfuric, and phosphoric.Appropriate organic acids may be selected, for example, from aliphatic,aromatic, carboxylic and sulfonic classes of organic acids, examples ofwhich are formic, acetic, propionic, succinic, glycolic, glucoronic,maleic, furoic, glutamic, benzoic, anthranilic, salicylic, phenylacetic,mandelic, embonic (pamoic), methanesulfonic, ethanesulfonic,pantothenic, benzenesulfonic, stearic, sulfanilic, algenic, andgalacturonic. Examples of such inorganic bases, for potential saltformation with the sulfate or phosphate compounds of the invention,include metallic salts made from aluminum, calcium, lithium, magnesium,potassium, sodium, and zinc. Appropriate organic bases may be selected,for example, from N,N-dibenzylethylenediamine, chloroprocaine, choline,diethanolamine, ethylenediamine, meglumaine (N-methylglucamine), andprocaine.

The compositions for use in the methods of the present invention mayinclude components such as suspensions, solutions and elixirs; aerosols;or other suitable carriers such as starches, sugars, microcrystallinecellulose, diluents, granulating agents, lubricants, binders,disintegrating agents, and the like, with the topical preparations beingpreferred.

Because of its ease of administration, shampoo represents the mostadvantageous topical dosage unit form, in which case liquidpharmaceutical carriers may be employed in the composition. Theseshampoos may be prepared as rinse-off or leave-on after-shampooproducts, as well as two stage treatment shampoos. Additionally, thecomposition may also be prepared as a stand-alone conditioner or pre- orpost-shampoo conditioner. In a preferred embodiment, the compositionsare administered as a shampoo, then as a conditioner after the shampoois rinsed away, and optionally in a higher concentration form, such as agel, subsequently thereto. Each of these forms is well understood bythose of ordinary skill in the art, such that dosages may easily beprepared to incorporate the pharmaceutical composition of the invention.

Pharmaceutical compositions for use in the methods of the presentinvention suitable for topical administration may be presented asdiscrete units including aerosol sprays, each containing a predeterminedamount of the active ingredient, as a powder, stick, or granules, ascreams (e.g., a conditioner), pastes, gels, lotions (e.g., a sunscreen),syrups, or ointments, on sponges or cotton applicators, or as a solutionor a suspension in an aqueous liquid, a non-aqueous liquid, anoil-in-water emulsion, or a water-in-oil liquid emulsion. Suchcompositions may be prepared by any of the methods of pharmacy, but allmethods include the step of bringing into association the carrier(s)with the active ingredient, which constitutes one or more necessaryingredients. In general, the compositions are prepared by uniformly andintimately admixing the active ingredient with liquid carriers or finelydivided solid carriers or both, and then, if necessary, shaping theproduct into the desired presentation.

Other suitable dosage forms include tablets, troches, capsules, patches,gel caps, magmas, lozenges, plasters, discs, suppositories, nasal ororal sprays, and the like. Tablets, capsules, and gel caps are thepreferred oral dosage unit form for the 5-α reductase inhibitor, inwhich case solid pharmaceutical carriers may be employed. If desired,tablets may be coated by standard aqueous or nonaqueous techniques.

In addition to the common dosage forms set out above, the compound foruse in the methods of the present invention may also be administered bycontrolled release means and/or delivery devices such as those describedin U.S. Pat. Nos. 3,845,770; 3,916,899; 3,536,809; 3,598,123; and4,008,719, the disclosures of which are expressly incorporated herein byreference thereto.

For example, a tablet may be prepared by compression or molding,optionally, with one or more accessory ingredients. Compressed tabletsmay be prepared by compressing in a suitable machine the activeingredient in a free-flowing form such as powder or granules, optionallymixed with a binder, lubricant, inert diluent, surface active ordispersing agent. Molded tablets may be made by molding, in a suitablemachine, a mixture of the powdered compound moistened with an inertliquid diluent.

Desirably, each unit dose, e.g., shampoo, contains from about 1 mg to2,000 mg of the active ingredient, preferably about 200 mg to 1,600 mg,and more preferably about 600 mg to 1,000 mg of the composition.

EXAMPLES

The invention is further defined by reference to the following examplesdescribing in detail the preparation of the compound and thecompositions used in the methods of the present invention, as well astheir utility. The examples are representative, and they should not beconstrued to limit the scope of the invention.

Example 1 Shampoo for Dandruff Treatment

A pharmaceutical composition according to the invention may be preparedin the form of a shampoo formulated for dandruff management as set forthbelow:

% by Ingredient Trade Name/Supplier Weight Part A Deionized Water N/A47   Guar Hydroxypropyltrimonium JAGUAR C-13S 0.1 Chloride Glycolic AcidGLYPURE-70% Glycolic Acid 1.5 Methylparaben Methylparaben 0.2 SodiumLaureth Sulfate CARSONOL SLES-2 28   Glycol Distearate LEXEMUL EGDS 1  Cocamidopropyl Betaine LONZAINE C 5   Part B Lauramide DiethanolamineMONAMID 716 2   (DEA) Part C Salicylic Acid Salicylic Acid, powdered,USP 1.2 Sodium Laureth Sulfate CARSONOL SLES-2 10   Part D AllantoinALLANTOIN 0.1 Panthenol DL-PANTHENOL 50% 0.3 Dimethicone (and) Laureth-4DOW CORNING 1664  0.05 and Laureth-23 Part E Clotrimazole Clotrimazole,USP 0.5 Alcohol (denatured) SD ALCOHOL 40, Anhydrous 1.5 Part F GlycolicAcid GLYPURE-70% Glycolic Acid  0.15 Phenoxyethanol Phenoxyethanol 0.7Methylchloroisothiazolinone KATHON CG  0.05 and MethylisothiazolinoneRetinyl Palmitate Vitamin A Palmitate, type P1.7  0.02 TocopherolVitamin E USP, #60525  0.02 Benzophenone-4 UVINUL MS-40 0.1 FD&C GreenNo. 3 FD&C Green No. 3  0.02 (CI 42053) (1.0% Solution) Ext. D&C VioletNo. 2 Ext. D&C Violet No. 2 0.2 (CI 60730) (0.10% Solution) Fragrance(Parfum) Natural Fragrance - Haarmann & 0.3 Reimer #A40758/778926 100%  JAGUAR C-13S is commercially available from Rhone-Poulenc N. AmericanChemicals of Cranbury, NJ; GLYPURE is commercially available from DuPontof Wilmington, DE; CARSONOL SLES-2 and LONZAINE C are commerciallyavailable from Lonza, Inc. of Fair Lawn, NJ; LEXEMUL EGDS iscommercially available from Inolex Chemical Co. of Philadelphia, PA;MONAMID 716 is commercially available from Mona Industries, Inc. ofPaterson, NJ; Allantoin is commercially available from ISP Corp. ofBound Brook, NJ; DL-PANTHENOL and UVINUL MS-40 are commerciallyavailable from BASF Corp. of Budd Lake, NJ; DOW CORNING 1664 iscommercially available from Dow Corning Corp. of Auburn, MI; KATHON CGis commercially available from Rohm & Haas Co. of Philadelphia, PA; FD&CGreen No. 3 and Ext. D&C Violet No. 2 are commercially available fromHilton-Davis Co. of Cincinnati, OH; and Natural Fragrance #A4-758/778926is commercially available from Haarmann & Reimer of Holzminden, Germany(subsidiary of Bayer Aktiengesellschaft).

Deionized water may be metered into the processing tank and high speedmixing subsequently begun. Guar hydroxypropyltrimonium and glycolic acidare added one at a time. Once the guar component is completelydispersed, the mixture is heated to 75° C. The remaining Part Aingredients are then added and mixed until all the solids are dissolved.The mixture is cooled to 60° C. and the Part B ingredients are added andmixed until uniform. The mixture is then cooled to 50° C. In a separatevessel, Part C is premixed until homogeneous, then added to the mixtureof Parts A & B. Parts A, B, and C are mixed until uniform. The Part Dingredients are added and mixed until uniform, then cooled to 40° C.Premixed Part E is added and mixed until uniform, the Part F ingredientsare added and mixed, and the composition is then cooled to 35° C. Theappearance should be an aqua blue, opaque, pearlized, semi-viscousliquid having a pH at 25° C. of between 4 to 5 and a viscosity between5,000 to 9,000 cps (RVT:#4 @ 10 rpm @25° C.).

Example 2 Shampoo for Thinning Hair

A pharmaceutical composition according to the invention may be preparedin the form of a shampoo formulated for management of thinning hair asset forth below:

% by Ingredient Trade Name/Supplier Weight Part A Deionized water N/A51.9  Polyquaternium-10 UCARE Polymer JR-125  0.15 Glycolic AcidGLYPURE-70% Glycolic Acid 1   Methylparaben N/A 0.2 Sodium LaurethSulfate CARSONOL SLES-2 35   Glycol Stearate LEXEMUL EGMS  0.75Phytantriol N/A 0.1 Sodium Lauroyl Sarcosinate HAMPOSYL L-30 1.5Cocamidopropyl Betaine LONZAINE C 5   Panthenyl Ethyl Ether EthylPanthenol 0.2 Tetrasodium Ethylene-Diamine- HAMP-ENE 220  0.03Tetraacetic Acid (EDTA) Benzophenone-4 Uvinul MS-40 0.1 Part B LauramideDiethanolamine MONAMID 716 2.2 Part C Lactamide Monoethanolamine (MEA)PARAPEL LAM-100 0.6 Sodium Peroxylinecarbolic Acid AJIDEW N-50 0.4 (PCA)Hair Keratin Amino Acids and Sodium CROTEIN HKP 0.1 Chloride Part D SawPalmetto (Serenoa Serrulata) Saw Palmetto Berry Glycolic 0.1 ExtractExtract Methylchloroisothiazolinone and KATHON CG  0.05Methylisothiazolinone FD&C Green No. 3 (CI 42053) FD&C Green No. 3 0.005 (1.0% Solution) FD&C Yellow No. 5 (CI 19140) FD&C Yellow No. 5 0.007 (1.0% Solution) Part E Menthol Menthol Crystals, USP 0.3 Cinnamon(Cinnamomum Cassia) Oil, Essential Oil Blend #EE-50098 0.5 Grapefruit(Citrus Grandis) Oil, Orange (Citrus Aurantium Dulcis) Oil, Petitgrain(Citrus Aurantium Amara) Oil, Peppermint (Mentha Piperita) Oil,Eucalyptus Globulus Oil, Clove (Eugenia Caryophyllus) Oil, and Rosemary(Rosmarinus Officinalis) Oil Fragrance (Parfum) Fragrance - Haarmann &Reimer 0.3 #A40758/778926 100%   UCARE Polymer JR-125 is commerciallyavailable from Amerchol Corp. of Edison, NJ; PHYTRANTIOL and ETHYLPANTHENOL are commercially available from Roche Vitamins Inc. ofParsippany, NJ; HAMPOSYL L-30 is commercially available from Hampshireof Lexington, MA; HAMP-ENE 220 is commercially available from Akzo NobelInc. of Dobbs Ferry, NY; PARAPEL LAM-100 is commercially available fromBernel Chemical Co. of Englewood, NJ; AJIDEW N-50 is commerciallyavailable from Ajinomoto USA Inc. of Teaneck, NJ; CROTEIN HKP iscommercially available from Croda Inc. of Parsippany, NJ; Saw Palmettois commercially available from Chart at Patterson, NJ; and FD&C GreenNo. 3 and Yellow No. 5 are commercially available from Hilton Davis Co.of Cincinnati, OH.

Deionized water may be metered into the processing tank and high speedmixing subsequently begun. Polyquaternium-10 and glycolic acid are addedone at a time. Once the polymer is completely dispersed, the mixture isheated to 75° C. The remaining Part A ingredients are then added andmixed until all the solids are dissolved. The mixture is cooled to 60°C. and the Part B ingredients are added and mixed until uniform. Themixture is then cooled to 50° C. In a separate vessel, Part C ispremixed until homogeneous, then added to the mixture of Parts A & B.Parts A, B, and C are mixed until uniform. The Part D ingredients areadded and mixed until uniform, then cooled to 40° C. Premixed Part E isadded and mixed until uniform, the Part F ingredients are added andmixed, and the composition is then cooled to 35° C. The appearanceshould be a light green, opaque, pearlized, semi-viscous liquid having apH at 25° C. of between 5.4 to 6.1 and a viscosity between 6,000 to12,000 cps (RVT: #5 @ 10 rpm @ 25° C.).

Example 3 Shampoo Formulation for Chemically Treated Hair

A pharmaceutical composition according to the invention may beformulated as a shampoo for protecting chemically treated hair as setforth below:

% by Ingredient Trade Name/Supplier Weight Part A Deionized water N/A86.4% Polyquaternium-10 UCARE Polymer JR-125 0.2 Glycolic AcidGLYPURE-70% Glycolic Acid 0.1 Tetrasodium Ethylene-Diamine- HAMP-ENE 220 0.01 Tetraacetic Acid (EDTA) Sodium Laureth Sulfate STEOL CS-230 PCK10   Glycol Stearate LEXEMUL EGMS 0.1 Methylparaben N/A  0.05 SodiumLauroyl Sarcosinate HAMPOSYL L-30 0.1 Panthenol Liquid DL-Panthenol 50%0.5 Benzophenone-4 UVINUL MS-40  0.05 Part B Disodium CocoamphodiacetateMIRANOL C2M CONC. NP 1   Part C Lactamide Monoethanolamine (MEA) PARAPELLAM-100 0.5 Sodium Peroxylinecarbolic Acid (PCA) AJIDEW N-50 0.5 HairKeratin Amino Acids and Sodium CROTEIN HKP  0.05 Chloride LaudimoniumHydroxypropyl HYDROTRITICUM QL  0.01 Hydrolyzed Wheat Protein Part DMethylchloroisothiazolinone and KATHON CG  0.05 MethylisothiazolinoneFD&C Red No. 40 (CI 16035) FD&C Red No. 40  0.02 (1.0% Solution) Part EJasmine (Jasminum Officinale) Oil, Essential Oil Blend “Passion” 0.3Palmarosa (Cymbopogon Martini) Oil, Sandalwood (Santalum Album) Oil,Patchouli (Pogostemon Cablin) Oil, Nutmeg (Myristica Fragrans) Oil,Grapefruit (Citrus Grandis) Oil, Orris (Iris Florentina) Root Oil,Carnation (Dianthus Caryophyllus) Oil Phytantriol N/A  0.02 Part FGlycolic acid GLYPURE-70% glycolic acid 0.1 Part G Deionized water N/A0.1 Sodium chloride N/A 0.1 100%   HYDROTRITICUM QL is commerciallyavailable from Croda Inc. of Parsippany, NJ; MIRANOL C2M is commerciallyavailable from Rhone-Poulenc N. American Chemicals of Cranbury, NJ;Phytantriol is commercially available from Roche Vitamins Inc. ofParsippany, NJ; and STEOL CS-230 PCK is commercially available fromStepan Co. of Northfield, IL.

Deionized water may be metered into the processing tank and high speedmixing subsequently begun. Polyquaternium-10 and glycolic acid are addedone at a time. Once the polymer is completely dispersed, the mixture isheated to 75° C. The remaining Part A ingredients are then added andmixed until all the solids are dissolved. The mixture is cooled to 60°C. and the Part B ingredients are added and mixed until uniform. Themixture is then cooled to 50° C. Part C is then added to the mixture ofParts A & B and mixed until uniform. The Part D ingredients are addedand mixed until uniform, then cooled to 40° C. Premixed Part E is addedand mixed until uniform, the Part F ingredients are added in incrementsas need to obtain the desired pH of 5.7 to 6.5 and mixed until uniform.Then Part G is added in increments to obtain the desired viscosity of8,000 to 12,000 cps (RVT#5 @ 10 rpm @ 25° C.), and the composition isthen mixed and cooled to 35° C. The appearance should be apeach-colored, opaque, pearlized, semi-viscous liquid having a pH at 25°C. of between 5.7 to 6.5 and a viscosity between 8,000 to 12,000 cps(RVT: #5 @ 10 rpm @ 25° C.).

Example 4 Professional Scalp Formulation for Dandruff

A pharmaceutical composition according to the invention may beformulated in a more potent concentration as a shampoo for professionalmanagement of dandruff as set forth below:

% By Ingredient Trade Name/Supplier Weight Part A Deionized water N/A74.6% Hydroxyethylcellulose CELLOSIZE QP52,000H 0.3 Part B DisodiumEthylene-Diamine- HAMP-ENE Na₂  0.03 Tetraacetic Acid (EDTA) GlycerinGlycerine 99.5% 1   Glycolic Acid GLYPURE-70% Glycolic 10   Acid Part CDeionized water N/A 1   Sodium Hydroxide Sodium Hydroxide, pellets 1  (USP/NF) Part D Alcohol (denatured) SD Alochol 40-B, Anhydrous 10  Salicylic Acid Salicylic Acid, powder 1.8 (USP/NF) Part EPPG-5-Ceteth-20 PROCETYL AWS 0.2 Lemongrass (Cymbopogon Lemongrass Oil#65161  0.02 Schoenanthus) Oil Peppermint (Mentha Piperita) OilPeppermint Oil #097973-  0.04 0594N Geranium Maculatum Oil Geranium Oil#01491  0.02 100%   HAMP-ENE Na₂ is commercially available from AkzoNobel Inc. of Dobbs Ferry, NY; and PROCETYL AWS is commerciallyavailable from Croda Inc. of Parsippany, NJ.

Deionized water may be metered into the processing tank and high speedmixing subsequently begun. CELLOSIZE QP52, 000H is added and heated at70° C until the solids are dissolved. The mixture is cooled to 40° C.The Part B ingredients are added and mixed until uniform. Premixed PartC is then added in increments to obtain the desired pH below, and mixeduntil uniform. The mixture is cooled to 25° C. and premixed part D isslowly added and mixed until uniform. Premixed Part E is added and mixeduntil uniform. The composition should be colorless, clear, semi-viscousliquid having a pH at 25° C. between 3.4 to 3.8 and a viscosity between1,500 to 2,5000 cps (RVT#5 @ 10 rpm @ 25° C.)

Example 5 Scalp Formulation for Thinning Hair

A pharmaceutical composition according to the invention may beformulated as a shampoo for management of thinning hair as set forthbelow:

% By Ingredient Trade Name Weight Part A Deionized water N/A 82.3% PartB Propylene Glycol N/A 5   Methylparaben N/A 0.2 Part C Menthol MentholCrystals,  0.03 USP Ethyl Nicotinate  0.05 Cinnamon (Cinnamomum Cassia)Oil, Grapefruit Essential Oil Blend  0.04 (Citrus Grandis) Oil, Orange(Citrus Aurantium #EE-50098 Dulcis) Oil, Petitgrain (Citrus AurantiumAmara) Oil Polysorbate 80 TWEEN 80 3   Phytantriol Phytantriol 0.2Biotin N/A 0.1 Salicylic Acid Salicylic Acid, 0.5 powder, USP/NFCapsicum Frutescens Extract and Safflower Actiphyte of  0.05 (CarthamusTinctorius) Oil Capsicum, Lipo S Part D Allantoin Allantoin 0.5Tetrasodium EDTA HAMP-ENE 220 0.2 Lactamide Monoethanolamine PARAPELLAM-100 1.5 Panthenyl Ethyl Ether Ethyl Panthenol 1.5 Diazolidinyl UreaGERMALL II 0.3 Cocamidopropyl PG-Dimonium Chloride PHOSPHOLIPID  1.08Phosphate PTC Saw Palmetto (Sereno Serrulata) Extract Saw PalmettoExtract 0.5 Cyanocobalamin Vitamin B₁₂  0.02 Yeast Extract (Faex) NAYADS 1   Yeast Extract (Faex) RESPIROGEN 2   100%   PHOSPHOLIPID PTC iscommercially available from Mona Industries Inc. of Patterson, NJ; andRESPIROGEN is commercially available from Immudyne, Inc. of Houston, TX.

Mix until uniform. Slowly add Part C to the batch. Mix until clear andhomogeneous. Add Part B ingredients in the given order, mixing wellafter each addition. Mix until completely uniform. The resultingcomposition should be a light golden yellow, clear, non-viscous liquidhaving a pH at 25° C. of between 3.6 to 4.2.

Example 6 Conditioner Formulation for Thinning Hair

A pharmaceutical composition according to the invention may beformulated as a

% By Ingredient Trade Name Weight Part A Deionized water N/A 79.5%Hydroxyethylcellulose CELLOSIZE POLYMER PCG-10 1   Methylparaben N/A 0.2Benzophenone-4 UVINUL MS-40 0.1 Glyceryl Stearate RITA GMS-55G 2  Stearalkonium Chloride MAQUAT SC-18 85% 2   Cetyl Alcohol LANETTE 16 2.5Stearyl Alcohol LANETTE 18 2.5 Glycerin Glycerine 99.5% 1   Part BLaurdimonium Hydroxypropyl Hydrolyzed HYDROTRITICUM QL 1   Wheat ProteinPanthenol DL-PANTHENOL 50% 1   Hydrolyzed Soy Protein HYDROSOY 2000 SF1   Hydrolyzed Wheat Protein Hydroxypropyl CRODASONE W 1   PolysiloxaneHair Keratin Amino Acids and Sodium CROTEIN HKP Powder 1   Chloride PartC Methylchloroisothiazolinone and KATHON CG  0.05 MethylisothiazolinoneBenzalkonium Chloride BTC-50 0.5 Biotin Biotin  0.05 Ethyl NicotinateEthyl Nicotinate  0.05 Witch Hazel (Hamamelis Virginiana) Witch HazelDistillate E02 2   Distillate FD&C Blue No. 1 (CI 42090) FD&C Blue No. 1 0.006 (1.0% Solution) FD&C Yellow No. 5 (CI 19140) FD&C Yellow No. 5 0.006 Part D Cinnamon (Cinnamomum Cassia) Oil, (1.0% Solution)Grapefruit (Citrus Grandis) Oil, Orange Essential Oil Blend 0.1 (CitrusAurantium Dulcis) Oil, Petitgrain #EE-50098 (Citrus Aurantium Amara)Oil, Peppermint (Mentha Piperita) Oil, Eucalyptus Globulus Oil, Clove(Eugenia Caryophyllus) Oil, Rosemary (Rosmarinus Officinalis) OilMenthol Fragrance (Parfum) Menthol Crystals, USP 0.5 Fragrance -HAARMANN & 0.5 Part E Glycolic Acid REIMER #A40758/778926 GLYPURE-70%Glycolic Acid 0.5 100%   CRODASONE W is commercially available fromCroda Inc. of Parsippany, NJ.

Preparation Procedure

Meter deionized water into the processing tank. Start high speed mixing.Sprinkle-in CELLOSIZE Polymer PCG-10.When the Polymer is completelydispersed, heat to 75° C. Add the remaining Part A ingredientsw. Mix at75° C. for 30 minutes until homogenous. Cool at 50° C. Add Part Bingredients. Mix until uniform. In a separate vessel, premix Part Duntil all the solids are dissovled. Add to the batch. Mix until uniform.Add Part E in increments as needed to obtain the desired pH. Continuemixing and cooling to 35° C. The resulting composition should have avery light green, opaque, semi-viscous appearance haveing a pH at 25° C.of between 3.8 to 4.5 and a viscosity between 7,000 to 11,000 cPs (RVT:#4 @ 10 rpm @ 25° C.).

Example 7 Professional Scalp Treatment for Chemically Treated Hair

A pharmaceutical composition according to the invention may beformulated in a higher concentration of acid as a professional treatmentfor protection of chemically treated hair as set forth below:

% By Ingredient Trade Name Weight Part A Deionized water N/A 73% Hydroxyethylcellulose CELLOSIZE QP52,000H 1   Part B Disodium EDTAHAMP-ENE Na₂   0.2 Glycerin Glycerine 99.5% 5   Panthenol LiquidDL-Panthenol 50% 1   Quaternium-75 FINQUAT CT   1.5 Cetrimonium ChlorideCARSOQUAT CT-429   1.5 Glycolic Acid GLYPURE-70% Glycolic 12   Acid PartC Deionized water N/A 2   Sodium Hydroxide Sodium Hydroxide, pellets,  1.5 USP/NF Part D PPG-5-Ceteth-20 PROCETYL AWS 1   Phytantriol   0.2Ylang Ylang (Cananga Odorata) Ylang Ylang Oil #65040  0.04 Oil Jasmine(Jasminum Officinale) Oil Jasmine Oil #65072  0.01 Chamomile (AnthemisNobilis) Oil Chamomile Oil #112528-  0.02 0395N 100%   FINQUAT CT iscommercially available from Finetex Inc. of Elmwood Park, NJ.

Preparation Procedure

Meter deionized water into the processing tank. Start high speed mixing.Sprinkle-in CELLOSIZE QP52, 000H. Heat to 70° C. Mix until all thesolids are completely dissolved, and the batch is clear and uniform.Cool to 40° C. Add Part B ingredients. Mix until uniform. Slowly addpremixed Part C ingredients in increments as needed to obtain thedesired pH. Mix until uniform. Add premixed Part D. Continue mixing andcooling to 35° C. The resulting composition should be a colorless topale straw-colored, clear, semi-viscous liquid having a pH at 25° C. ofbetween 3.4 to 3.8 and a viscosity between 2,500 to 3,500 cPs (RVT: #3 @10 rpm @ 25° C.).

Example 8 Professional Scalp Management of Thinning Hair

A pharmaceutical composition according to the invention may beformulated in a higher concentration of acid for professional managementof thinning hair as set forth below:

% By Ingredient Trade Name Weight Part A Deionized water N/A 77.5%Hydroxyethylcellulose CELLOSIZE 1   QP52,000H Part B Disodium EDTAHAMP-ENE Na₂ 0.2 Glycerin Glycerine 99.5% 5   Panthenyl Ethyl EtherEthyl Panthenol 1   Glycolic Acid GLYPURE-70% 12   Glycolic Acid Part CDeionized water N/A 1.8 Sodium Hydroxide Sodium Hydroxide, 1   pellets,USP/NF Part D PPG-5-Ceteth-20 PROCETYL AWS 0.2 Phytantriol Phytantriol0.2 Ethyl Nicotinate Ethyl Nicotinate  0.05 Menthol Menthol Crystals,USP  0.03 Cinnamon (Cinnamomum Cassia) Oil Cinnamon Oil #65028  0.02Rosemary (Rosmarinus Officinalis) Oil Rosemary Oil #65138  0.03Peppermint (Mentha Piperita) Oil Peppermint Oil  0.02 #097973-0594N100%  

Preparation Procedure

Meter deionized water into the processing tank. Start high speed mixing.Sprinkle-in Cellosize QP52,000H. Heat to 70° C. Mix until all the solidsare completely dissolved, and the batch is clear and uniform. Cool to40° C. Add Part B ingredients. Mix until uniform. Slowly add premixedPart C in increments as needed to obtain the desired pH. Mix untiluniform. Add premixed Part D. Continue mixing and cooling to 35° C. Theresulting composition should be a colorless to pale straw-colored,clear, semi-viscous liquid having a pH at 25° C. between 3.4 to 3.8 anda viscosity between 2,200 to 3,500 cPs (RVT: #3 @ 10 rpm @ 25° C.).

Example 9 Conditioner for Chemically Treated Hair

A pharmaceutical composition according to the invention may beformulated as a conditioner for chemically treated hair as set forthbelow:

% By Ingredient Trade Name Weight Part A Deionized water N/A 88%  GuarHydroxypropyltrimonium Chloride JAGUAR C-13S 0.5 Glycolic AcidGLYPURE-70%  0.15 Glycolic Acid Methylparaben N/A  0.15 StearalkoniumChloride MAQUAT SC-18 85% 2   Cetyl Alcohol LANETTE 16 2   StearylAlcohol LANETTE 18 2   Trimethylsilylamodimethicone SF 1708-D1 0.5Sodium PCA AJIDEW N-50  0.05 Benzophenone-4 UVINUL MS-40 0.1 Part BHydrolyzed Wheat Protein and CROPEPTIDE W 0.1 Hydrolyzed Wheat StarchHydrolyzed Wheat Protein CRODASONE W 0.5 Hydroxypropyl PolysiloxanePanthenol Liquid DL-Panthenol 1   50% Hydrolyzed Soy Protein HYDROSOY2000 SF 1   Phytantriol Phytantriol 0.3 Polyquaternium-11 GAFQUAT 755N1   Part C Methylchloroisothiazolinone and KATHON CG  0.05Methylisothiazolinone Benzalkonium Chloride BTC-50 0.3 FD&C Red No. 40(C1 16035) FD&C Red No. 40  0.012 (1.0% Solution) Jasmine (JasminumOfficinale) Oil, Essential Oil Blend 0.3 Palmarosa (Cymbopogon Martini)Oil, “Passion” Sandalwood (Santalum Album) Oil, Patchouli (PogostemonCablin) Oil, Nutmeg (Myristica Fragrans) Oil, Grapefruit (CitrusGrandis) Oil, Orris (Iris Florentina) Root Oil, Carnation (DianthusCaryophyllus) Oil 100%   GAFQUAT 775N is commercially available from ISPCorp. of Bound Brook, NJ.

Preparation Procedure

Meter deionized water into the processing tank. Start high speed mixing.Sprinkle-in Jaguar C-13S. Add Glypure. When the Jaguar is completelydispersed, heat to 75° C. Add the remaining Part A ingredients. Mix at75° C. for 30 minutes until homogeneous. Cool to 50° C. Add Part Bingredients. Mix until uniform. Cool to 40° C. Add Part C ingredients.Continue mixing and cooling to 35° C. The resulting composition shouldbe light peach-colored, opaque, semi-viscous, having a pH at 25° C.between 4 to 4.8 and a viscosity between 8,000 to 12,000 cPs (RVT: #4 @10 rpm @ 25° C.).

Various modifications of the invention in addition to those shown anddescribed herein will be apparent to those skilled in the art from theforegoing description. Such modifications are also intended to fallwithin the scope of the appended claims. The foregoing disclosureincludes all the information deemed essential to enable those skilled inthe art to practice the claimed invention.

What is claimed is:
 1. A method of treating an infectious or scalingscalp condition which comprises topically applying to the scalp of apatient in need thereof a therapeutically effective amount of each of anacidic component which is a hydroxy acid, or a pharmaceuticallyacceptable salt thereof, a vitamin A component, and an anti-growth agentto inhibit fungus, or yeast, or a mixture thereof.
 2. The method ofclaim 1, wherein the scalp condition treated is at least one ofdandruff, seborrheic dermatitis, psoriasis, or folliculitis.
 3. Themethod of claim 1, wherein the applying is by at least one of a shampoo,aerosol spray, gel, paste, cream, lotion, sponge, emulsion, or ointment.4. The method of claim 1, wherein about 1 mg to 10,000 mg of the acidiccomponent, vitamin A component, and anti-growth agent are togetheradministered.
 5. The method of claim 1, wherein the acidic component,vitamin A component, and anti-growth agent are administeredconcurrently.
 6. The method of claim 1, wherein the acidic component,vitamin A component, and anti-growth agent are administered concurrentlywith at least one additional pharmaceutical composition for theprevention or treatment of the scalp condition.
 7. The method of claim1, which further comprises administering at least one of a surfactant,stabilizer, preservative, moisturizer, anti-inflammatory agent,anti-oxidant, or coloring agent.
 8. The method of claim 1, wherein theacidic component comprises an alpha-hydroxy acid or beta-hydroxy acid,the vitamin A component comprises retinyl palmitate, and the anti-growthagent comprises at least one of triclosan or clotrimazole.